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Biomedical subjects

E Magnus Ohman

Publications and source records attributed to E Magnus Ohman.

At least 73 records · Page 4Linked to original sources

Tenecteplase and tirofiban in ST-segment elevation acute myocardial infarction: results of a randomized trial.

BACKGROUND: The combination of older reduced-dose fibrinolytic agents and platelet glycoprotein IIb/IIIa inhibitors has shown modest improvements in reperfusion and more striking improvements in ST-segment resolution after acute myocardial infarction. We performed a multicenter dose-ranging study of reduced doses of a newer fibrinolytic (tenecteplase) combined with tirofiban, a glycoprotein IIb/IIIa inhibitor. METHODS: The first goal of the trial was to identify a dose or doses of tirofiban that, when combined with reduced-dose tenecteplase, would result in a higher incidence of Thrombolysis In Myocardial Infarction (TIMI) grade 3 flow at 60 minutes versus full-dose tenecteplase alone. The second goal was to assess whether the optimum dose(s) from the first stage also would result in greater resolution of ST-segment elevation. RESULTS: In all, 409 patients aged 18 to 75 years with myocardial infarction were enrolled. The incidence of TIMI grade 3 flow at 60 minutes did not differ significantly among dose groups, ranging from 50% to 68%. The corrected TIMI frame count likewise did not differ substantially (range 34-42). More patients given combined therapy had complete resolution of ST-segment elevation at 60 minutes compared with patients given tenecteplase alone. Major bleeding was infrequent, and no strokes occurred. Based on angiographic results of the first stage, the second planned stage of the study was not performed. CONCLUSIONS: Although combination therapies were not associated with increased reperfusion compared with full-dose tenecteplase alone, similar TIMI flow grades were achieved despite reductions in tenecteplase doses. ST-segment resolution was more rapid and complete with combination therapy versus full-dose tenecteplase, suggesting enhanced microcirculatory perfusion to the infarct zone in this dose-ranging trial.

Adolescent↗

Association of intravenous morphine use and outcomes in acute coronary syndromes: results from the CRUSADE Quality Improvement Initiative.

BACKGROUND: Although intravenous morphine is commonly used for the treatment of chest pain in patients presenting with non-ST-segment elevation acute coronary syndromes (NSTE ACS), its safety has not been evaluated. The CRUSADE Initiative is a nonrandomized, retrospective, observational registry enrolling patients with NSTE ACS to evaluate acute medications and interventions, inhospital outcomes, and discharge treatments. METHODS: The study population comprised patients presenting with NSTE ACS at 443 hospitals across the United States from January 2001 through June 2003 (n = 57,039). Outcomes were evaluated in patients receiving morphine versus not and between patients treated with morphine versus intravenous nitroglycerin. RESULTS: A total of 17,003 patients (29.8%) received morphine within 24 hours of presentation. Patients treated with any morphine had a higher adjusted risk of death (odds ratio [OR] 1.48, 95% CI 1.33-1.64) than patients not treated with morphine. Relative to those receiving nitroglycerin, patients treated with morphine also had a higher adjusted likelihood of death (OR 1.50, 95% CI 1.26-1.78). Utilizing a propensity score matching method, the use of morphine was associated with increased inhospital mortality (OR 1.41, 95% CI 1.26-1.57). The increased risk of death in patients receiving morphine persisted across all measured subgroups. CONCLUSIONS: Use of morphine either alone or in combination with nitroglycerin for patients presenting with NSTE ACS was associated with higher mortality even after risk adjustment and matching on propensity score for treatment. This analysis raises concerns regarding the safety of using morphine in patients with NSTE ACS and emphasizes the need for a randomized trial.

Acute Disease↗

Pulmonary artery catheterization in acute coronary syndromes: insights from the GUSTO IIb and GUSTO III trials.

PURPOSE: To correlate pulmonary artery catheterization (PAC) use and 30-day outcomes and to characterize the use of pulmonary artery catheters among patients with acute coronary syndromes (ACS). SUBJECTS AND METHODS: We retrospectively studied 26437 ACS patients from two large multicenter, international randomized clinical trials. Multivariable and causal inference analyses were applied to adjust for differences in baseline risk. RESULTS: PAC was performed in 735 patients (2.8%), with a median time to insertion of 24 hours. Patients undergoing PAC were older (median, 67 vs. 64 years), more often diabetic (25.7% vs.16.2%), and more likely to present with ST-segment elevation (81.6% vs. 70.2%) or Killip class III or IV (7.9% vs. 1.4%). US patients were 3.8 times more likely than non-US patients to undergo PAC. Patients managed with PAC also underwent more procedures, including percutaneous intervention (40.7% vs. 18.1%), coronary artery bypass grafting (12.5% vs. 7.7%), and endotracheal intubation (29.3% vs. 2.2%). Mortality at 30 days was substantially higher among patients with PAC for both unadjusted (odds ratio [OR] 8.7; 95% confidence interval [CI] 7.3-10.2) and adjusted analyses (OR 6.4; 95% CI 5.4-7.6) in all groups except in patients with cardiogenic shock (OR 0.99; 95% CI 0.80-1.23). CONCLUSIONS: PAC was associated with increased mortality, both before and after adjustment for baseline patient differences and subsequent events that may have led to PAC use, except in patients with cardiogenic shock. The definitive role of PAC in managing patients with ACS is still to be determined.

Acute Disease↗

Influence of timing of troponin elevation on clinical outcomes and use of evidence-based therapies for patients with non-ST-segment elevation acute coronary syndromes.

STUDY OBJECTIVE: Previous studies in clinical trial populations have demonstrated that patients presenting with positive troponin levels have a higher risk of mortality than patients with later positive troponin levels, but the influence of the timing of troponin elevation has not been previously characterized. We evaluate the impact of the timing of troponin elevation on clinical outcomes and adherence to the American College of Cardiology/American Heart Association acute care guidelines for patients with non-ST-segment elevation acute coronary syndromes. METHODS: We examined inhospital outcomes and use of acute (<24 hours) medications and invasive cardiac procedures in 23,184 high-risk patients with non-ST-segment elevation acute coronary syndromes (positive cardiac markers or ischemic ST-segment changes) during 2001 to 2002 from 396 US hospitals participating in the Can Rapid Risk Stratification of Unstable Angina Patients Suppress ADverse Outcomes with Early Implementation of the American College of Cardiology/American Heart Association Guidelines (CRUSADE) Initiative. Baseline and peak troponin values were recorded and were designated as positive if above the cutoff value used at each institution to designate definite myocardial necrosis. RESULTS: In the study cohort, 53.2% of patients presented with baseline positive troponin levels, 30.6% had baseline negative/later positive troponin levels, and 16.2% had negative troponin levels during the entire hospitalization. Patients with baseline positive troponin levels had a higher risk of inhospital mortality than patients with baseline negative/later positive troponin levels (6.5% versus 4.1%) and were less likely to undergo early cardiac catheterization or percutaneous coronary intervention. The use of acute aspirin (in approximately 91% of patients), heparin (85%), and beta-blockers (78%) was similar in patients with baseline-positive versus later-positive troponin levels. CONCLUSION: These findings demonstrate that evidence-based therapies and interventions for non-ST-segment elevation acute coronary syndromes are underused in patients with elevated troponin levels, but baseline troponin elevations, which are associated with a higher risk of inhospital mortality, do not stimulate more aggressive care.

Acute Disease↗

Practical implementation of the Guidelines for Unstable Angina/Non-ST-Segment Elevation Myocardial Infarction in the emergency department.

In the United States each year, >5.3 million patients present to emergency departments with chest discomfort and related symptoms. Ultimately, >1.4 million individuals are hospitalized for unstable angina and non-ST-segment elevation myocardial infarction. For emergency physicians and cardiologists alike, these patients represent an enormous challenge to accurately diagnose and appropriately treat. This update of the 2002 American College of Cardiology/American Heart Association Guidelines for the Management of Patients with Unstable Angina and Non-ST-Segment Elevation Myocardial Infarction (UA/NSTEMI) provides an evidence-based approach to the diagnosis and treatment of these patients in the emergency department, in-hospital, and after hospital discharge. Despite publication of the guidelines several years ago, many patients with UA/NSTEMI still do not receive guidelines-indicated therapy.

Angina, Unstable↗

Are international differences in the outcomes of acute coronary syndromes apparent or real? A multilevel analysis.

STUDY OBJECTIVE: International variation in the outcomes of patients with acute coronary syndromes (ACS) has been well reported. The relative contributions of patient, hospital, and country level factors on clinical outcomes, however, remain unclear, and thus, was the objective of this study. DESIGN: Multilevel logistic regression models were developed for death/(re)infarction (MI) at 30 days and death in one year, with patients (1st level) nested in hospitals (2nd level) and hospitals in countries (3rd level). SETTINGS: The GUSTO IV ACS clinical trial was carried out at 458 hospital sites in 24 countries. PATIENTS: 7800 non-ST segment elevation (NSTE) ACS patients. MAIN RESULTS: There were substantial variations among countries in the processes and outcomes of care at 30 days, ranging from 5.4% to 50.0% for percutaneous coronary intervention, 4.3% to 21.2% for coronary artery bypass graft surgery, 5.0% to 13.9% for 30 day death/(re)MI, and 4.9% to 14.8% for one year mortality. However, the residual inter-country variations in 30 day death/(re)MI and one year mortality became non-significant and nearly disappeared (p > 0.500 for both) after adjusting for key baseline patient characteristics and hospital factors, which became significant (p < 0.01 for both). Patient level factors accounted for 96%-99% of total variation in these end points, leaving the remaining 1% and 4% of variance attributable to hospital level factors. CONCLUSION: The international differences in clinical outcomes in this study of NSTE ACS are primarily accounted for by the patient level factors, with hospital level factors playing a minor part, and the country level factors a negligible one. These findings have significant policy and research implications involving international collaboration and comparisons.

Abciximab↗

Early glycoprotein IIb/IIIa inhibitor use for non-ST-segment elevation acute coronary syndrome: patient selection and associated treatment patterns.

OBJECTIVES: The authors analyzed contemporary use of glycoprotein (GP) IIb/IIIa inhibitors in patients with non-ST-segment elevation acute coronary syndrome (NSTE ACS) to determine patient selection patterns with early (<24 hours) GP IIb/IIIa inhibitor use and the relationship between GP IIb/IIIa inhibitor therapy and use of other guidelines-recommended therapies for NSTE ACS. METHODS: Using the CRUSADE Quality Improvement Initiative database, patient characteristics, in-hospital treatments, and outcomes for 65,424 patients with ischemic chest pain of <24 hours' duration and either positive cardiac markers or ischemic electrocardiographic changes were analyzed. Data were collected from 443 U.S. hospitals from January 2001 to June 2003. RESULTS: Only 35% of eligible patients received GP IIb/IIIa inhibitors <24 hours after hospital admission. Approximately one third of patients received GP IIb/IIIa inhibitors in the emergency department, one third in the coronary care unit, and one third in the catheterization laboratory. Admission to a cardiologist's care was the most significant associated factor with early GP IIb/IIIa inhibitor use, along with elevated cardiac markers or ST-segment deviation. Patients at high risk for adverse cardiac events due to advanced age, congestive heart failure, or female gender were less likely to receive early GP IIb/IIIa inhibitor therapy. Patients who received early GP IIb/IIIa inhibitor therapy were more likely to receive other guidelines-recommended therapies. CONCLUSIONS: Despite the American College of Cardiology/American Heart Association (ACC/AHA) guidelines recommendations, early GP IIb/IIIa inhibitor therapy remains underutilized in patients with NSTE ACS and administration of early GP IIb/IIIa inhibitors is directed toward lower-risk patients. Early GP IIb/IIIa inhibitor therapy is associated with improved overall adherence to the ACC/AHA guidelines.

Acute Disease↗

Utilization of early invasive management strategies for high-risk patients with non-ST-segment elevation acute coronary syndromes: results from the CRUSADE Quality Improvement Initiative.

CONTEXT: The American College of Cardiology/American Heart Association (ACC/AHA) guidelines for the management of non-ST-segment elevation acute coronary syndromes (NSTE ACS) recommend early invasive management for high-risk patients, given the benefits with this approach demonstrated in randomized clinical trials. OBJECTIVES: To determine the use and predictors of early invasive management strategies (cardiac catheterization <48 hours following presentation) in high-risk patients with NSTE ACS and to examine the association of early invasive management with mortality. DESIGN, SETTING, AND PATIENTS: The CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines) Quality Improvement Initiative evaluated care patterns and outcomes for 17,926 high-risk NSTE ACS patients (positive cardiac markers and/or ischemic electrocardiographic changes) based on ACC/AHA guidelines recommendations at 248 US hospitals with catheterization and revascularization facilities between March 2000 and September 2002. MAIN OUTCOME MEASURES: Use of early invasive management within 48 hours of presentation, predictors of early invasive management, and in-hospital mortality. Results Of the 17,926 patients analyzed, 8037 (44.8%) underwent early cardiac catheterization less than 48 hours following presentation. Predictors of early invasive management included cardiology care, younger age, lack of prior or current congestive heart failure, lack of renal insufficiency, ischemic electrocardiographic changes, positive cardiac markers, white race, and male sex. Patients treated with early invasive management were more likely to be treated with medications and interventions recommended by the ACC/AHA guidelines and had a lower risk of in-hospital mortality after adjusting for differences in clinical characteristics and after comparing propensity-matched pairs (2.5% vs 3.7%, P<.001). Conclusions An early invasive management strategy is not utilized in the majority of high-risk patients with NSTE ACS. This strategy appears to be reserved for patients without significant comorbidities and those cared for by cardiologists and is associated with a lower risk of in-hospital mortality.

Aged↗

In-hospital mortality associated with the use of intra-aortic balloon counterpulsation.

We analyzed in-hospital mortality for patients treated with intra-aortic balloon counterpulsation from the Benchmark Counterpulsation Outcomes Registry (n = 25,136). In-hospital mortality was higher in patients who received only medical interventions (32.5%) than in those who underwent percutaneous (18.8%) and surgical (19.2%) interventions, and was greatest in the first days after hospital admission for all 3 intervention types. Therefore, diagnostic evaluation and treatment decisions should be made as early as possible, and physicians should be aware of associated risk factors in making choices for patients.

Aged↗

Effect of multielement intravascular ultrasound on the anticoagulant potency of enoxaparin.

Two patients, treated with enoxaparin and eptifibatide, developed significant guide catheter-associated thrombus while undergoing intravascular ultrasound (IVUS). Using an ex vivo assay, we found that activation of a multielement IVUS catheter resulted in a decrease in anti-Xa activity and a decrease in clot formation time. This effect occurred rapidly and repeatedly after activation of the IVUS catheter.

Aged↗

The clinician as investigator: participating in clinical trials in the practice setting.

The rapid development of new drugs, therapies, and devices has created a dramatic increase in the number of trials needed to properly evaluate them. The majority of patients treated today, many of whom could be eligible for participation in these studies, are seen in community hospitals and medical practices that are not affiliated with an academic medical center. Thus, there is a demonstrable need for physicians in private practice to enlist as investigators in these trials. This article is intended to encourage those physicians by describing the need and providing the rationale for their participation. It covers basic requirements for participating in clinical trials and outlines ethical, regulatory, financial, and other logistical issues of importance for the potential investigator and provides an algorithm for selecting a study for participation. Finally, the appendices review basic elements of study design and statistical principles, which may be of interest to a potential investigator.

Choice Behavior↗

Percutaneous coronary intervention in a patient with immune thrombocytopenia purpura.

The appropriate regimen of platelet inhibitors that should be used in patients with immune thrombocytopenia purpura (ITP; formerly called idiopathic thrombocytopenic purpura) who are undergoing percutaneous coronary intervention is unclear. We report the case of a patient with ITP who underwent two separate coronary interventions. The first involved the use of aspirin and a cutting balloon to treat obstructive disease of the left circumflex. When the patient presented with restenosis, he received eptifibatide, clopidogrel, and an intracoronary stent. He is currently 16 months removed from his second procedure and remains physically active without any anginal symptoms. Percutaneous revascularization in patients with ITP remains a challenge and this therapeutic approach, while ultimately successful in the patient, requires further validation.

Aged↗

Implications of elevated cardiac troponin T in ambulatory patients with heart failure: a prospective analysis.

BACKGROUND: Elevated concentrations of cardiac troponin T (TnT) have been reported in patients hospitalized for decompensated heart failure (HF). We assessed whether elevated TnT levels are associated with the severity, etiology, and prognosis of HF in stable, ambulatory patients. METHODS: From 1998-1999, we prospectively collected data from 136 ambulatory patients with HF, New York Heart Association functional class II to IV, ejection fraction < or =35%, and no recent unstable angina, myocardial infarction, surgery, or coronary revascularization. Blood was obtained and analyzed by immunoassay for TnT, and patients were followed for 14.0 +/- 4.3 months for death or HF hospitalization (primary end point) and other adverse cardiovascular outcomes. RESULTS: Thirty-three patients (24%) had an elevated TnT level (> or =0.02 ng/mL). Mean TnT concentration did not differ by etiology of HF (0.002 +/- 0.03 ng/mL vs 0.02 +/- 0.04 ng/mL for ischemic and nonischemic etiologies, P =.25). Compared with patients with normal (undetectable) levels of TnT, patients with elevated TnT were significantly older, had worse functional class, and had poorer renal function. Elevated TnT concentrations were associated with increased relative risks (RR) of death or HF hospitalization (RR 2.7, 95% CI 1.7-4.3, P =.001) and death alone (RR 4.2, 95% CI 1.8-9.5, P =.001) during follow-up. Elevated TnT and New York Heart Association class were significant, independent predictors of death or HF hospitalization. Increased age and serum creatinine concentrations were significant independent predictors of death alone. CONCLUSIONS: Nearly one fourth of ambulatory patients with chronic HF have ongoing myocardial necrosis as shown by abnormal TnT values, which are associated with increased mortality and morbidity.

Aged↗

Bleeding events with abciximab in acute coronary syndromes without early revascularization: An analysis of GUSTO IV-ACS.

BACKGROUND: The glycoprotein IIb/IIIa receptor antagonist abciximab reduces the risk of thrombotic complications with percutaneous coronary intervention, but also has been associated with higher bleeding rates. METHODS: In the Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes (GUSTO IV-ACS) trial, abciximab (either a 24-hour or 48-hour infusion) was compared with placebo in 7800 patients with an acute coronary syndrome. During study drug administration, 2% of the patients underwent a revascularization procedure. RESULTS: In 1507 patients (19.3%), bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) classification was observed while they were hospitalized or within 7 days. Ninety-eight patients (1.2%) had a major bleed, including 8 with intracranial hemorrhages. In 215 patients (2.8%), a minor bleed was reported, and in 1194 patients (15.3%), an insignificant bleed was reported. Bleeding was more frequent in patients receiving a 48-hour infusion of abciximab. Spontaneous bleeding was seen in 911 patients (11.7%). The other 596 patients had a bleeding event in conjunction with a procedure. The most significant predictors for bleeding with multivariable analysis were: use of low-molecular weight heparin, duration of abciximab infusion, region of hospitalization, performance of coronary artery bypass grafting or percutaneous coronary intervention (PCI), advanced age, and female sex. For major bleeding, the predictors were performance of coronary artery bypass grafting or PCI, long duration of abciximab administration, and advanced age. CONCLUSION: Treatment with abciximab in patients with non-ST-elevation acute coronary syndromes is safe because major bleeding and stroke are rare, and most events are clinically manageable or have few clinical consequences. Guidelines for use of abciximab in combination with other antithrombotic agents developed for PCI should also be respected in acute coronary syndromes. Specific dosing guidelines for combination with low-molecular weight heparin must be developed for patients who subsequently will undergo a PCI.

Abciximab↗

Prognostic value of predischarge electrocardiographic measurement of infarct size after thrombolysis: insights from GUSTO I Economics and Quality of Life substudy.

BACKGROUND: Current methods for risk stratification after acute myocardial infarction (MI) include several noninvasive studies. In this cost-containment era, the development of low-cost means should be encouraged. We assessed the ability of an electrocardiogram (ECG) MI-sizing score to predict outcomes in patients enrolled in the Economics and Quality of Life (EQOL) sub study of the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries -I (GUSTO-I) trial. METHODS: We classified patients by electrocardiographic Selvester QRS score at hospital discharge: those with a score 0-9 versus > or =10. Endpoints were 30-day and 1-year mortality, resource use, and quality-of-life measures. RESULTS: Patients with a QRS score <10 were well-matched with those with QRS score > or =10 with the exception of a trend to more anterior MI in the higher scored group. Patients with QRS score > or =10 had increased risk of death at 30-days (8.9% vs. 2.9% P < .001), and this difference persisted at 1 year (12.6% vs. 5.4%, P = .001). Recurrent chest pain, use of angiography, and angioplasty were similar during follow-up. However, there was a trend toward less coronary bypass surgery in patients with a QRS score > or =10. Readmission rates were higher at 30 days but similar at 1 year. CONCLUSIONS: Stratification of patients after acute MI by a simple measure of MI size identifies populations with different long-term prognoses; patients with a QRS score > or =10 (approximately 30% of the left ventricle infarcted) at discharge have poorer outcomes in both the short- and long-term. The standard 12-lead ECG provides a simple, economical means of risk stratification at discharge.

Electrocardiography↗